Original SiloSheath, Size 3, Antibac
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Original SiloSheath, Size 3, Antibac FDA UDI
- Generic Name
- External limb prosthesis socket liner FDA UDI
- Device Name
- Antibacterial Silosheath™ - Size 3 (Short/Regular): - 1 Per Box EUDAMED
- Model / Reference
- 14435 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00614464144356 EUDAMEDFDA UDI
- Basic UDI-DI
- 0614464144355K EUDAMED
- FDA Product Code
- IPM FDA UDI
- EMDN Code
- Y090618 LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS) EUDAMED
- GMDN Term
- External limb prosthesis socket liner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: External limb prosthesis socket liner
Original SiloSheath, Size 3, Antibac by SILIPOS Holding LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SILIPOS Holding LLC
Sources (2)
- FDA UDI 9f78b620-751e-4780-a170-f47928eef8d1 32 fields · synced Sep 17, 2026
- EUDAMED 73468ae0-6fe9-42df-8717-7253bec9a072 61 fields · synced Sep 17, 2026